Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:13 AM
Ignite Modification Date:
2025-12-26 @ 11:13 AM
NCT ID:
NCT00330928
Eligibility Criteria:
Inclusion Criteria:
* \>=18yrs and undergoing elective or non-emergent PCI of a de novo native coronary artery lesion
* Treatment plan (at time of consent and at time of intervention) must be to perform an intervention on no more than 2 lesions, where one is the culprit lesion and the other lesion requires revascularization at the discretion of the treating physician.
* Target lesion should have "low-risk" characteristics(defined by angiography)
* Subject must be able to read, understand and sign an approved informed consent form and follow protocol
* Female subjects of child bearing potential must have a negative serum pregnancy test prior to enrollment
Exclusion Criteria:
* Evidence of Clinical instability in the 6 hours before the procedure, or at any time during the procedure (72 hours stable post-STEMI)
* Angiographically Unsuitable Coronary and/or Lesion Morphology in the culprit vessel.
* A contraindication to anticoagulation or increased risk of bleeding.
* Clinically significant abnormal laboratory findings
* Presence of a drug eluting stent in the artery for experimental study prior to NIR measurement, unless all struts are covered by endothelium as documented by IVUS
* Elective PCI on or through bypass grafts or LIMA grafts
* Allergy or intolerance to aspirin or clopidogrel
* Planned use of laser ablation, rotational ablation, brachytherapy, or atherectomy device
* Enrollment or participation in any other medication trial within the previous 30 days
* Current enrollment participation or enrolled in another clinical trial
* Any other factor that the investigator feels would put the patient at increased risk if participating in the protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00330928
Study Brief:
Protocol Section:
NCT00330928